The eyelids 14, lashes 12, and ocular surface tear film 20 are a complex, integrated system that serves to protect the eye 10, maintain comfort, and enable optimal vision. FIG. 1 illustrates components of the eye 10 and its associated systems. As will be appreciated by those skilled in the art, there are a number of eyelid and lash disorders that can disrupt this protective system.
One such condition is anterior blepharitis which is treated by applying a compress to the eyelid and lashes (moist or dry, cool or warm) followed by a lid scrub (suitable lid scrubs includes, OCuSOFT® LidScrub™ and AVR SteriLid®). Mechanical scrubbing is still required to debride and remove the exudates. The OCuSOFT Lid Scrub facilitates removal of oil, debris, and desquamated skin from the eyelids. OCuSOF Lid Scrub Original Formula is recommended for routine daily eyelid hygiene, while the OCuSOFT Lid Scrub PLUS “Leave-On” Formula is an extra strength formulation and recommended for moderate-severe eye conditions. The PLUS Formula prolongs contact maximizing bacterial time kill eradicating seven different strains of bacteria common to the eyelids including MRSA and Staph epi.
The OCuSOFT pre-moistened lid scrub eyelid cleansers contains Water, PEG-80 Sorbitan Laurate, Sodium Trideceth Sulfate, PEG-150 Distearate, Disodium Lauroamphodiacetate, Cocamidopropyl Hydroxysultaine, Sodium Laureth-13 Carboxylate, Sodium Chloride, PEG-15 Cocopolyamine, Quaternium-15. The OCuSOFT Lid Scrub PLUS contains: Water, Ringer's Solution, POE-80 Sorbitan Monolaurate, Methyl Gluceth-20, PEG-120 Methyl Glucose Dioleate, Decyl Polyglucoside, 1,2-Hexanediol and 1,2-Octanediol, Cocoamphodiacetate Disodium, D-Panthenol, Polyaminopropyl Biguanide (PHMB).
Another condition is meibomian gland dysfunction or disease (MGD). An approach to treatment of MGD has been the application of a warm compress to the eyelids (applied externally, from the skin side of the eyelids). The purpose of the warm compress is to dilate the tissue around the meibomian glands and to heat the meibomian gland oil above its melting point allowing it to thin, decrease its viscosity, and flow again.
As will be appreciated by those skilled in the art, current treatments focus on one or another of a range of disorders, and require patient compliance with sometimes complex treatment regimens, adherence to very inconvenient protocols, or simply do not work because the treatment regimens require the patient to use home remedies that are not always safe and are highly variable.
Some products are currently available such as warm compresses. Lid scrubs are also commercially available as described above.
TearScience® provides an electric massager of fixed frequency combined with heat from inside the eyelid, and Gulden Ophthalmics provides a mechanical roller providing massage. See, U.S. Des. 617,443 S to Grenon et al. issued Jun. 8, 2010, for “Eye Treatment Goggles;” U.S. Pub 2011/0022010 A1 to Grenon et al. published Jan. 27, 2011, for “Method and Apparatus for Treating Meibomian Gland Dysfunction Employing Fluid Jet”; U.S. Pub. 2010/0256552 A1 to Korb et al. published Oct. 7, 2010, for “Method and Apparatus for Treating Meibomian Gland Dysfunction” U.S. Pat. No. 7,833,205 B2 issued Nov. 16, 2010, to Grenon et al. for “Methods for Treating Meibomian Gland Dysfunction Employing Fluid Jet;” U.S. Pub. 2008/0132978 A1 published Jun. 5, 2008, to Korb et al. for “Outer Eyelid Heat and Pressure Treatment for Treating Meibomian Gland Dysfunction;” and 2007.0027431A1 published Feb. 1, 2007, to Korb et al. for “Treatment of Meibomian Glands.”
Pharmaceutical modalities such as the use of tetracycline have also been suggested to treat MGD and one such treatment is disclosed in US Pub US 2003/0114426 A1 published Jun. 19, 2003, to Pflugfelder et al. for “Method for Treating Meibomian Gland Disease;” U.S. Pat. No. 6,455,583 B1 issued Sep. 24, 2002, to Pflugfelder et al. for “Method for Treating Meibomian Gland Disease;” and PCT Publication No. WO 99/58131 A1 published Nov. 18, 1999, to Pflugfelder et al. for “Use of Tetracyclines for Treating Meibomian Gland Disease.” The use of corticosteroids have also been proposed to treat meibomian gland dysfunction as disclosed in U.S. Pat. No. 6,153,607 issued Nov. 28, 2000, to Pflugfelder et A1 for “Non preserved Topical Corticosteroid for Treatment of Dry Eye, Filamentary Keratitis, and Delayed Tear Clearance (or Turnover).”
Additionally, the use of topically applied androgens or androgen analogues have also been used to treat acute dry eye signs and symptoms in as disclosed in U.S. Pat. No. 5,958,912 issued Sep. 28, 1999, and U.S. Pat. No. 6,107,289 issued Aug. 22, 2000, to Sullivan for “Ocular Therapy in Keratoconjunctivitis Sicca Using Topically Applied Androgens or TGF-β.”
One modality for the heat treatment of MGD is disclosed in US Pub. US 2006/0018953 A1 published Jan. 26, 2006, to Guillon et al. for “Eyelid Margin Wipes Comprising Chemical Means for Temperature Adjustment.” As disclosed in Guillon's patent application, a wipe is provided wherein prior to use, a chemical agent is activated that will heat the wipe to about 32° C. to about 40° C. The heated wipe is then applied to the lids and manual expression can then be used to unclog the ducts.
U.S. Pat. No. 6,908,195 B2 issued Jun. 21, 2005, to Fuller for “Therapeutic Eye and Eye Lid Cover” comprises a pair of goggles that are adapted to deliver heated saturated air to the eyelids and particularly to the meibomian glands, again to heat the gland. U.S. Pat. No. 7,069,084 B2 issued Jun. 27, 2006, to Yee for “Method and Apparatus for Preventing and Treating Eyelid Problems” attempts to clear the plugged meibomian glands by means of electrical stimulation of the muscle of Riolan which the Yee device attempts to stimulate in order to aid in the expression of the meibomian gland secretion.
What is needed is a modular, integrated, easy to use, convenient, safe, and effective device, system and method to manage the range of disease entities. Since the diseases represent a continuum of conditions, a device, system and method that is adjustable to a patient's specific expression of physiologic issues would be desirable.